and Human Services (HHS)
EXPIRED
Cancer Nanotechnology Platform Partnerships
RFA Number: RFA-CA-05-026
Part I Overview InformationDepartment of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Catalog of Federal Domestic Assistance Numbers
93.393, 93.399
Key Dates
Release Date: November 30, 2004
Letter of Intent Receipt Date: February 25, 2005
Application Receipt Date: March 25, 2005
Peer Review Date: June/July 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 2005
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: March 26, 2005
Due Dates for E.O. 12372
Not Applicable
Executive Summary
The National Cancer Institute (NCI) invites applications for research project grants (RPGs) to support development of nanotechnology platforms for basic, applied, and translational multi-disciplinary research that uses nanotechnology (e.g., nanoscale devices or nanomaterials less than 1000 nm in size, although the assembly, synthesis, and/or fabrication of components at dimensions less than 300 nm should be demonstrated ) in cancer research. Proposed projects will be eligible for consideration if they address one or more of the following thematic/programmatic areas of focus: molecular imaging and early detection, in vivo imaging, reporters of therapeutic efficacy, multifunctional therapeutics, prevention and control of cancer, and research enablers. The NCI intends to commit approximately 7 million dollars in FY 2005 to fund approximately 10 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total costs up to 1 million dollars per year.
Eligible organizations include f or-profit or non-profit organizations, public or private institutions (such as universities, colleges, hospitals, and laboratories), units of State and local governments, eligible agencies of the Federal government, and domestic institutions/organizations. Foreign institutions are not eligible to apply, but an application may include collaborative work at a foreign site when the expertise at the foreign site is not present in the United States. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his or her eligible institution to develop an application for support. An applicant may submit one application in response to this RFA. Application materials are available from the NIH Office of Extramural Research (OER; http://grants.nih.gov/grants/oer.htm). Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Table of Contents
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Award Criteria
4. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement1. Research Objectives
The National Cancer Institute (NCI) invites applications for research project grants (RPGs) to support development of nanotechnology platforms for basic, applied, and translational multi-disciplinary research that uses nanotechnology (e.g., nanoscale devices or nanomaterials less than 1000 nm in size, although the assembly, synthesis, and/or fabrication of components at dimensions less than 300 nm should be demonstrated ) in cancer research. In the context of this program, a multi-disciplinary research team must be assembled to apply an integrative, systems approach to develop knowledge and/or methods to prevent, detect, diagnose, or treat cancer. The research team must include appropriate bioengineering or allied physical/computational sciences in combination with biomedical and/or clinical components to address a cancer-related focus. The Principal Investigator (PI) serves as the project manager and must be capable of leading the proposed effort. The research team may propose design-directed, developmental, discovery-driven, or hypothesis-driven research at universities, national laboratories, medical schools, large or small businesses, or other public and private entities or combinations of these entities. It is expected that in the application the team will present a well-defined goal or deliverable that will be achieved based on objective milestones specified for the overall project period. This RFA uses components of team engineering approaches such as Bioengineering Research Partnerships (BRPs; http://grants2.nih.gov/grants/guide/pa-files/PAR-04-023.html) and Bioengineering Research Grants (BRGs; http://grants2.nih.gov/grants/guide/pa-files/PAR-02-011.html). This RFA supports the NCI's Alliance for Nanotechnology in Cancer, which is detailed below.
Current clinical cancer-related nanotechnology research has demonstrated advances in areas such as laboratory-based diagnostics (e.g., nanowires, quantum dots, lab-on-a-chip applications), in vivo diagnostic imaging (e.g., contrast agents, implantable biosensors), and therapeutics (e.g., dendrimers, engineered virus particles, multifunctional nanodevices). These developments will provide insight into the understanding and measurement of numerous aspects of the tumor microenvironment, including the production of growth signals, and the regulation of apoptosis, angiogenesis, replication, metastasis, and genomic instabilities. Nanotechnology encompasses a broad range of novel materials, strategies, and devices, and the intent of this RFA is to benefit basic biological and preclinical research by increasing the variety of available nanotechnologies for cancer and to catalyze their development and commercialization by the public or private sector.
It is expected that nanotechnology will enable numerous applications in cancer research and treatment, including (but not limited to):
The NCI Alliance for Nanotechnology in Cancer. Nanotechnology's dimensions and multifunctional capabilities enable investigators to study and interact with normal and cancer cells in real time, at the molecular and cellular scales, and during the earliest stages of the cancer process. Nanotechnology will be a mission-critical tool to meet the NCI's Challenge Goal of eliminating the suffering and death due to cancer. To enable nanotechnology to become a fundamental driver of advances in oncology and cancer research, the NCI has developed a series of directed programmatic mechanisms known collectively as the Alliance for Nanotechnology in Cancer (http://nano.cancer.gov). The Alliance is an integrated 5-year initiative to develop and apply nanotechnology to cancer prevention, detection, diagnosis, and treatment. The ultimate goal of the Alliance is to benefit the cancer patient through the delivery of novel therapeutics and enhanced diagnostic tools.
The three core elements of the Alliance for Nanotechnology in Cancer are:
NCI Resources. The Alliance is designed to integrate nanotechnology research and development (R&D) with existing NCI resources that includes Comprehensive Cancer Centers (http://www3.cancer.gov/cancercenters/), Specialized Programs of Research Excellence (http://spores.nci.nih.gov/), and the Early Detection Research Network (http://www3.cancer.gov/prevention/cbrg/edrn/). CCNEs will also engage with relevant NCI initiatives such as the Developmental Therapeutics program (http://dtp.nci.nih.gov/docs/raid/raid_index.html), the Academic Public Private Partnership Program (http://grants2.nih.gov/grants/guide/rfa-files/RFA-CA-04-005.html), the Development of Clinical Imaging Drug Enhancers program (http://www3.cancer.gov/bip/dcide.htm), the Integrative Cancer Biology Program (http://dcb.nci.nih.gov/branchdetail.cfm?branch=1), the Innovative Molecular Analysis Technologies program (http://otir.nci.nih.gov/tech/imat.html), Unconventional Innovations Program (http://otir.nci.nih.gov/tech/uip.html), the Fundamental Technologies for Biomolecular Sensors program (http://otir.nci.nih.gov/tech/ftbs.html), and the Mouse Models of Human Cancer Consortium (http://emice.nci.nih.gov/). These linkages will increase the visibility and availability of nanomaterials and nanoscale device technology within the cancer research and development communities, and they will promote further collaboration with other Federal agencies. Respondents to this RFA will be expected to integrate scientific approaches, collaborate in design and testing of nanotechnology platforms, and share common resources and data with the Steering and Governance Committee of the Cancer Centers of Nanotechnology Excellence.
Objectives
Successful application of nanotechnology to cancer research requires an understanding of how synthetic materials developed from the atomic-level interface with biological systems that are relevant to genetic, cellular, and molecular features of cancer. Thus, the success of the Alliance initiatives hinges upon the breakthroughs of multidisciplinary research teams whose combined expertise extends beyond the individual disciplines of traditional biological and clinical sciences. Bioengineering integrates principles from a diversity of technical and biomedical fields and crosses the boundaries of many scientific disciplines represented throughout academia, laboratories, and industry. The creativity of these interdisciplinary teams will be a central component of cancer nanotechnology, as it results in new basic understandings and in innovative platform technologies that lead to diagnostic and therapeutic delivery systems.
The primary objective of this RFA is to encourage basic, applied, and translational scientific and engineering methods through multidisciplinary team approaches to create new nanoscale platform technologies that are relevant to cancer processes. A nanotechnology platform is characterized in the following section (see below). By integrating physical, engineering, and computational science principles with biological and clinical applications, bioengineering research can advance fundamental concepts, create knowledge from the molecular to the organ systems level, and develop innovative materials, devices, and informatics approaches to prevent, detect, diagnose, and treat cancer. Applicants for this RFA may propose research that leads to novel devices, and partnerships with companies that have relevant expertise or that may eventually be involved in commercialization are appropriate under this program.
A second objective is to encourage collaborations and partnerships among the allied quantitative and biomedical disciplines that interface with cancer research. An applicant must bring together the necessary physical, engineering, and computational science expertise with biological or clinical expertise and resources to address a significant area of targeted cancer research in one or more of six thematic areas (see below). In addition to the benefits to be derived from the research, the collaborations and partnerships can create opportunities for trans-disciplinary communication and training for a new generation of scientists capable of interacting across traditional technical boundaries. As such, applicants for this RFA will be expected to collaborate with researchers at the NCI Centers of Cancer Nanotechnology Excellence and utilize all appropriate collaborative opportunities catalyzed by the Alliance.
Nanotechnology Platforms. The National Nanotechnology Initiative (NNI; http://nano.gov/html/facts/whatIsNano.html) characterizes nanotechnology as meeting the following criteria: 1) Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 - 100 nanometers; 2) Creating and using structures, devices, and systems that have novel properties and functions because of their small and/or intermediate size; and 3) Having the ability to control or manipulate on the atomic scale. For the purposes of this application, applicants are encouraged to use the NNI definition as a guideline, with the following addenda: 1) Applicants must propose research platforms or base materials that are less than 1000 nm in size, although the assembly, synthesis, and/or fabrication of components at dimensions less than 300 nm should be demonstrated ; and 2) Projects must incorporate synthetic or engineered materials or biomaterials that have been engineered to become nanomaterials (e.g., carbon nanotubes). Projects that propose only the use of unmodified, naturally-occurring materials (e.g., carbohydrates, proteins, baculovirus) will be considered not responsive and will be returned to the applicant without review.
For reference purposes, nanotechnology platforms that are appropriate for this RFA include but are not limited to base particles such as: dendrimers, carbon-based nanostructures (e.g., nanotubes, nanopores), perfluoroctylbromide (PFOB), Polyacrylamide/Sol-Gel Silica, peptide nucleic acids/PNA-peptides, immunoliposomes, SiO2/pS and polymer micelles, and virus- and carbohydrate-based hydrogels. Contrast agents based on gadolinium, iron, gold, technetium, indium or copper, as well as engineered fluorophores, are also appropriate. Applicants are encouraged to consider new biomaterial composites as their physicochemical properties address problems of biological significance such as biofouling, protein aggregation, etc. Examples of base platforms include but are not limited to: nanowires, cantilevers, quantum dots, biomolecular sensors, nanoshells, nanoparticles, nanoscale harvesters, nanochannels, imaging agents and methods, and integrated, lab-on-a-chip diagnostic tools.
Cancer Focus Areas. In accordance with the principles of the Alliance, the NCI has identified six thematic/programmatic areas of focus for directed nanotechnology-based research platforms where nanotechnology can have a pronounced impact in the short- and long-terms. These areas of interest are described below :
1) Molecular imaging and the early detection of cancer - Novel nanotechnologies can complement and augment existing genomic and proteomic techniques to analyze variations across different tumor types, thus offering the potential to distinguish between normal and malignant cells. Sensitive biosensors constructed of nanoscale components (e.g., nanocantilevers, nanowires, and nanochannels) can recognize genetic and molecular events and have reporting capabilities, thereby offering the potential to detect rare molecular signals associated with malignancy. Such signals may then be collected for analysis by nanoscale harvesters that selectively isolate cancer-related molecules from tissues. Another area with near-term potential for early detection is the identification of mutations and genomic instability in situ .
2) In vivo imaging - A pressing need in clinical oncology is for imaging methods (e.g., optical, magnetic resonance-based, ultrasound) that can identify tumors that are orders of magnitude smaller than those detected with current technology. When utilized in conjunction with powerful contrast agents, coupled with nanoparticles such as dendrimers, these methods can improve targeting capability and increase signal intensity. In the future, implantable nanoscale biomolecular sensors may enable clinicians to more carefully monitor the disease-free status of patients who have undergone treatment or individuals susceptible to cancer because of various risk factors. Furthermore, imaging agents that target changes in the environment surrounding a tumor, such as angiogenesis, will further augment methodologies and will be invaluable to obtain optimal benefit from therapeutics that target such specific cancer-related processes.
3) Reporters of therapeutic efficacy - Nanotechnology offers the potential to develop highly sensitive imaging-based devices and ex vivo diagnostics that can determine whether a therapeutic agent is reaching its intended target and whether that agent is killing malignant or support cells. Optical imaging devices that use nanoscale agents may also enable surgeons to more readily detect the margins of a tumor prior to resection or to detect micrometastases in lymph nodes or tissues distant from the primary tumor. Nanoparticle-based systems to detect apoptosis or reactivation of the p53 system and targeted nanoparticles that can bind to a tumor and be re-released into the bloodstream as tumor cells undergo apoptosis following therapy represent another potential application of nanotechnologies as reporters of efficacy.
4) Multifunctional therapeutics - Because of their multifunctional capabilities, nanoscale devices can contain both targeting agents and therapeutic payloads, particularly in areas of the body that are difficult to access because of a variety of biological barriers, including those developed by tumors. Multifunctional nanoscale devices also offer the opportunity to utilize new approaches to therapy, such as localized heating or reactive oxygen generation, and to combine a diagnostic or imaging agent with a therapeutic and/or a reporter of therapeutic efficacy. Smart nanotherapeutics may provide clinicians with the ability to time the release of an anticancer drug or deliver multiple drugs sequentially in a timed manner or at several locations in the body, potentially ushering in an era of sustained therapy for cancers that must be treated chronically. Such nanotherapeutics could also house engineered cellular factories that make and secrete proteins and other antigrowth factors that impact a tumor and/or its immediate environment. Many nanotherapeutics (e.g., nanoparticulate hydrogels, nanoparticles, and quantum dots) can also double as imaging agents.
5) Prevention and control of cancer - Many of the advances that nanotechnology will enable in each of the four preceding areas will also find widespread applicability in efforts to prevent and control cancer. Once specific biomarkers of cancer susceptibility and precancerous lesions have been identified, nanotechnology can enable devices that signal their presence and deliver targeted therapy. Nanoscale devices may also prove valuable for delivering polyepitope cancer vaccines that engage the immune system or for delivering cancer-preventing nutraceuticals or other chemopreventive agents in a sustained, time-release and targeted manner.
6) Research enablers - Nanotechnology offers a wide range of tools, from chip-based nanolabs capable of monitoring and manipulating individual cells to nanoscale probes that can track the movements of cells, and even individual molecules, as they move about in their environment. Using such tools will enable cancer biologists to study, monitor, and alter the multiple systems that are implicated in cancer processes and identify key biochemical and genetic targets for future molecular therapies. As such, nanotechnology can complement other technology platforms, such as proteomics and bioinformatics. Another near-term application of nanotechnology to accelerate basic research is to use molecular-size nanoparticles with a wide range of optical properties (e.g., quantum dots) to track individual molecules or cells as they move through local environments, thereby monitoring multiplexed cellular and molecular events in real time. When combined with mouse models that reproduce the genetic, biochemical, and physiological properties of human cancers, these nanolabels will be useful for integrative, systems biology research. Finally, nanoscale devices that enable simultaneous biochemical measurements (e.g., time, size, dynamic events) on multiple cells, particularly those grown in such a way as to mimic tissue development in vivo , will bring new dimensionality to basic cancer research.
While the NCI has identified these specific programmatic research areas, the Institute recognizes the breadth and scope of current cancer nanotechnology projects. The specific cancer nanotechnology applications described under each thematic/programmatic area are provided only as examples to highlight the diverse tools and strategies of cancer nanotechnology research supported by this RFA.
Quantitative Milestones. All applications for nanotechnology platform awards must include a specific section labeled Milestones. Milestones should be submitted annually (at a minimum) and should be well-described, quantitative, scientifically justified and not simply a restatement of the specific aims. Rather, the milestones should offer a timeline and a pathway for the development of the proposed technology. These milestones will be used to judge the success of the proposed research and to evaluate the criteria for the program. Applications that lack quantitative milestones as determined by the NCI program staff will be returned to the applicant without review.
Section II. Award Information1. Mechanism of Support
This funding opportunity will use the R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise, follow the instructions for non-modular research grant applications.
2. Funds Available
The NCI intends to commit approximately 7 million dollars in FY 2005 to fund ten new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total costs up to 1 million dollars per year.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The NCI will look to fund a variety of proposals in terms of scale and scope. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The RFA may be reissued in the future, contingent upon the availability of funds.For new grants, the maximum total (direct plus facilities and administrative [F&A] costs) budget to be awarded in any year is $1 million.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Foreign institutions are not eligible to apply as Principal Investigators. However, collaborative projects may include work at a foreign site when the expertise at the foreign site is not present in the United States.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
Applications for renewal or supplementation of existing projects are not eligible to compete with applications for new awards supported by this RFA.
2. Cost Sharing
This program does not require cost sharing.
3. Other-Special Eligibility Criteria
Research Focus Areas: Applicants must state how their proposed project(s) support of one or more of the six thematic/programmatic areas of focus for directed nanotechnology-based research platforms listed in the RESEARCH OBJECTIVES section of this RFA. Applicants should clearly describe how their proposed projects will address fundamental principles of cancer biology (e.g., apoptosis, metastasis, protein folding and assembly, DNA repair, recognition of mutational deletions in lymphocytes, cell cycle regulation, loss of heterozygosity) at the molecular and/or sub-cellular levels in terms of the biology and chemistry involved (e.g., energy transfer and cellular thermodynamics, surface properties and phenomena, molecular self-assembly). Emphasis should be placed on why the approach is revolutionary within the context of related research and how it will overcome biological barriers and interfere with the biological processes involved in carcinogenesis.
Section IV. Application and Submission Information1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo, Telephone: (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
1. Page limitations for both new and competing continuation applications have been increased to a maximum of 40 pages from the usual 25-page limit for sections A-D of the "Research Plan." Applicants are encouraged to be concise and use fewer pages.
2. Description page - In addition to the information requested on Form Page 2, identify in the Description the name(s) of the institution(s) leading the project and other participating institutions. The Description should clearly indicate the area(s) of cancer nanotechnology research that will be the focus of the application, the planned multi-disciplinary approach, and the specific objective of the project.
To provide recognition of the essential contributions of partners who provide significant intellectual leadership to the nanotechnology platform project, applicants are strongly encouraged to include information about Lead Investigators in the Description, which becomes publicly accessible. Lead Investigators are those who provide essential scientific, engineering, technical, and visionary leadership to the effort. In the past, applications might have listed such individuals as Key Personnel. Include in the Description the following information about each Lead Investigator: name, institution if different from the applicant organization, and one sentence about the leadership role. The description of the roles of Lead Investigators should be provided in greater detail in the narrative for personnel in the budget section.
The Lead Investigators will usually include the Principal Investigator and a subset of the Key Personnel. The following information is provided to clarify the roles of the various individuals who are to be named on this page. NIH grants policy requires that each application designate a single Principal Investigator (PI) who: (1) is responsible for the overall scientific and technical direction of the effort; and (2) serves as the contact person with whom NIH staff will interact. Lead Investigators provide essential scientific, engineering, technical, and visionary leadership to the effort. Key Personnel are those individuals who contribute in a substantive way to the scientific or engineering development or execution of the project.
3. An organization chart (OC) that clearly defines the partnership and relationships among its various components must be included with the application. A project plan (PP) should accompany the OC and list major tasks with a timeline of quantitative milestones for the entire project period. The OC and PP must not exceed one page each. This information should be included along with the Research, Design, and Methods section of the application.
4. Nanotechnology Platform Budget Items - A separate budget for each partner at a subcontract/consortium institution, and when appropriate for clarity, for each partner within the grantee institution must be included. Include a summary budget for all research team participants with partners at non-grantee institutions shown as consortium arrangements. It is understood that this is an initial budget, and that the PI has the responsibility to reallocate funds during the project to accomplish the platform development goals. Rebudgeting of funds must be done in accordance with the NIH Grants Policy Statement found at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm.
The NCI will not provide annual support in excess of $1 million total cost for any year for new applications. Direct cost inflationary increases following the first year may be included, but the maximum total cost request level of $1 million per year must be observed. Negotiated costs assessed by partnering organizations do not need to be included in direct costs.
The PI is expected to devote a minimum of 25 percent effort to the proposed project. The percent effort requested for all personnel should be limited to time devoted specifically to project activities and not to other research projects. Information documenting the level of effort on project-related activities should be included in the application. The need for all requested personnel costs should be thoroughly justified.
There will be an annual meeting of the Alliance for Cancer Nanotechnology at a date and location to be determined by NIH staff. Applicants should include travel funds specifically for these meetings in the budget request.
Applicants may request and justify additional travel funds. Travel funds could be used to promote collaboration among partners at different institutions or at a distant site, for travel of external advisors to the collaborating site, and/or for partners to attend scientific meetings essential to the progress of the project and for which other funds are not available.
Other expenses can be requested including costs necessary for the central administration and fiscal management of the research team including relevant and reasonable costs for reprints, graphics, and publications.
With regard to projected funding by source, some applicants may anticipate or receive commitments for significant funding from sources other than the NIH (e.g., from a collaborating company). Applicants are responsible to verify that terms and conditions under other funding from non-NIH sources, if any, must not conflict with the terms and conditions under any NIH funding agreement, if awarded.
5. Resources - The application should describe the equipment and facilities available for the proposed research project.
If the project entails an institutional commitment of resources across boundaries in the institution or anticipates the provision of institutional resources, letters from appropriate senior-level individuals describing their agreements to support those commitments must be included.
Where appropriate, describe the shared facilities to be established including specific major research instruments and plans for the development of instruments. Describe plans for maintaining and operating the facilities including staffing, provisions for user fees, and plans for ensuring access to outside users. Distinguish between existing facilities and those still to be developed.
6. Research Plan
A. Specific Aims A research team may propose design-directed, developmental, discovery-driven, or hypothesis-driven research focused on yielding nanotechnology platforms. Thus, the application should state the hypotheses, designs, problems, and/or needs that will drive the proposed research. Describe the specific aims in the appropriate area of cancer research and the quantitative milestones for the nanotechnology development project period. The quantitative milestones should occupy a separate section and be consistent with the requirements under the section above on Objectives. Describe the expected cancer applications of the nanotechnology platform that will improve human health. One page is recommended.
B. Background and Significance - Briefly describe the area of cancer research that is the focus of the nanotechnology development project. Critically evaluate existing knowledge and approaches that have been or are being applied in the area and specifically describe how the proposed approach will advance the field. State concisely the importance and health relevance of the research proposed to achieve the Specific Aims.
C. Preliminary Studies and Rationale - Preliminary studies that support the proposed research should be described in the application.
D. Research Design and Methods - A research project should focus on developing nanotechnology platforms as previously described to address a specific area or problem in cancer research within the six areas previously described, with the direct goal of enabling cancer research and clinical application. The research plan should be sufficiently long term and comprehensive to justify organizing a research team and adaptable enough to permit change as the research proceeds. The integrative systems approach and its appropriateness for the proposed project should be described including plans for collecting, analyzing, and interpreting data. A timetable of events including quantitative milestones or other evaluative criteria should be included. The contributions of each partner and how these will be integrated and organized to accomplish the specific aims of the project should be described. Potential technical challenges and possible alternative approaches to achieve the aims of the project should be discussed. Plans for enhancing the abilities and opportunities for investigators and trainees to work across disciplinary boundaries should also be included. If the proposed research and technology development is closely related to ongoing research and technology development, explain how the research activities of the proposed team will complement but not overlap the existing research.
7. NIH expects applications to include a plan for making available to the research community any technologies developed or enhanced by work conducted as part of the request for applications. The plan should include ordering of authors and provision for publication/recognition of the contributions of each essential co-author. This plan should be described in the Research Design and Methods section of the application. Investigators using PHS funds are required to make unique research resources readily available for research purposes to qualified individuals within the scientific community when the results have been published. The intent of this policy is not to discourage, impede, or prohibit the organization that develops the unique research resources or intellectual property from commercializing the products. Refer to Section IV.6. for details of required data and research resource sharing plans as well as the just-in-time requirements for intellectual property management plans.
3. Submission Dates
Applications must be received on or before the receipt date described in Section IV.3.A..
3.A. Receipt, Review and Anticipated Start Dates
Release Date: November 30, 2004
Letter-of-Intent Receipt Date: February, 2005
Application Receipt Date: March 25, 2005
Peer Review Date: June/July 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 2005
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter-of-intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Gregory J. Downing, D.O., Ph.D.
Director, Office of Technology and Industrial Relations
Office of the Director
National Cancer Institute, NIH, DHHS
Building 31, Room 10A-52, MSC 2580
31 Center Drive
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional copies of the application and all five copies of the appendix material must be sent to:
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]
Appendices should be comprised of unbound materials with separators between documents.
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Award Criteria).
6. Other Submission Requirements
RESEARCH TEAM ORGANIZATIONAL STRUCTURE, LEADERSHIP, AND MANAGEMENT: An organizational structure that clearly defines the partnership and relationships among the various components must be developed and described in the application; the size, structure, and mode of operation should match the needs and scope of the proposed research. NIH policy requires that a single PI be designated on the face page of all applications. While this individual is responsible for the scientific and technical aspects, as well as the proper conduct of the project, the structure of the proposed nanotechnology platform project may involve more than one individual in developing the application and in making decisions concerning planning, management, staffing, and resource allocation. In recognition of the essential intellectual and/or technical contributions of the lead scientists responsible for developing and implementing the goals of the proposal, the organizational structure must include a Leadership Statement that specifies the roles of the individuals that provide major intellectual and/or technical contributions. The PI has the responsibility and authority to use funds in the most productive way to achieve the goals defined at the time of the award. To accomplish these tasks, the PI in collaboration with other individuals identified in the Leadership Statement can adjust funding among research team participants to support new partners or to reduce support to existing partners as needed. Please note the use of funds is governed by NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). The research proposal should establish a Scientific Steering Group that consists of representatives from each of the partnering organizations and meets regularly to discuss project status, problems, and directions. Those individuals identified in the Leadership Statement, who together would have the intellectual and leadership responsibilities normally attributed to the PI, would likely be members of the Scientific Steering Group.
NANOTECHNOLOGY PLATFORM PI MEETING: PIs will meet annually to share results, to ensure that the NIH has a coherent view of the advances in these fields, and to have an opportunity for collective problem solving among the PIs. The cost of participating in this annual meeting should be included in the budget.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
All applicants are expected to include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity are expected to include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
Intellectual Property Management PlanGuidance for Preparation of Research Tools Sharing Plan and Intellectual Property Plan.
Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research. The NIH is interested in ensuring that the research resources developed through this grant also become readily available to the broader research community in a timely manner for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public health.
Investigators conducting biomedical research frequently develop unique research resources. The policy of the NIH is to make available to the public the results and accomplishments of the activities that it funds. To address this interest in ensuring research resources are accessible, NIH expects applicants who respond to this RFA to submit a plan: (1) for sharing the research resources generated through the grant (e.g., human biospecimens and novel cancer biomarkers); and (2) addressing how they will exercise intellectual property rights, should any be generated through this grant, while making such research resources available to the broader scientific community consistent with this initiative. Therefore, such research resources tools sharing plan and intellectual property management plans would make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/ and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 http://ott.od.nih.gov/NewPages/64FR72090.pdf) ( NIH Research Tools Guidelines Policy ). These documents also: (1) define terms, parties, and responsibilities; (2) prescribe the order of disposition of rights and a chronology of reporting requirements: and (3) delineate the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page (http://www.iedison.gov); url not working see also, 35 USC 210(c); Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and Memorandum on Government Patent Policy (Feb. 18, 1983). If applicant investigators plan to collaborate with third parties, the research tools sharing plan would need to address how such collaborations would not restrict their ability to share research materials produced with NIH funding. The applicant's institution should avoid exclusively licensing those inventions that are research tools, unless either: (1) the field of use of the exclusive license is restricted to commercial use, or (2) the exclusive licensee will make the research tool broadly available on reasonable terms.
Intellectual property management plans are a just-in-time requirement; it is not necessary to include the final plan approved by all parties in the grant application, but final, approved plans will be expected before a U54 grant can be awarded. NIH program staff will consider the adequacy of the plans in determining whether to recommend an application for award. The approved plans would become a condition of the grant award and Progress Reports must contain information on activities for the sharing of research resources and intellectual property.
In the development of any research resource sharing and intellectual property management plans, applicants should confer with their institutions' office(s) responsible for handling technology transfer related matters and/or sponsored research. If applicants or their representatives require additional guidance in preparing such plans, they are encouraged to make further inquiries to the appropriate contacts listed above for such matters. Further, applicants may wish to independently research and review examples of approaches considered by other institutions such as those described on the NCI Technology Transfer Branch web site (http://ttc.nci.nih.gov/intellectualproperty/). The foregoing guidance is provided by way of example to assist applicants in preparing the expected research resources sharing and intellectual property management plans in a manner that encourages partnerships with industry. While these approaches will likely suit most situations, these approaches are not exclusive and applicants should feel free to submit alternative versions for consideration.
The majority of transfers to not-for-profit entities should be implemented under terms no more restrictive than the Uniform Biological Materials Transfer Agreement (UBMTA) (http://ott.od.nih.gov/NewPages/UBMTA.pdf). In particular, recipients are expected to use the Simple Letter Agreement (SLA) provided at http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf , or another document with no more restrictive terms, to readily transfer unpatented tools developed with NIH funds to other recipients for use in NIH-funded projects. If the materials are patented or licensed to an exclusive provider, other arrangements may be used, but commercialization option rights, royalty reach-through rights, or product reach-through rights back to the provider are inappropriate. Similarly, when for-profit entities are seeking access to NCI-funded tools for internal use purposes, recipients should ensure that the tools are transferred with the fewest encumbrances possible. The Simple Letter Agreement (SLA) may be expanded for use in transferring tools to for-profit entities, or simple internal use license agreements with execution or annual use fees may be appropriate.
Section V. Application Review Information1. Criteria
Only the criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
3. Merit Review Criteria
The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance : Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Is the research likely to have a significant impact on other areas of research? Will the technological advances have a significant impact on clinical care of cancer patients?
Approach: Are the engineering, scientific, and clinical approaches of the research team partnership integrated on the proposed project? Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is a timetable with adequate, quantitative milestones for the research proposed? Are appropriate specifications and evaluation procedures provided for assessing technological progress? Is the plan for sharing or disseminating technologies developed or enhanced under this program announcement adequate?
Is the plan for technology transfer involving each partnering organization adequate? Does the application describe arrangements that facilitate the fruitful participation of a partner at a distant site? If partnership with industry or small business is included, does this positively affect the research goals and technology dissemination?
Innovation: Does the project employ novel concepts, approaches or methods that combine engineering, physical, and clinical sciences ? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Will the proposed approaches or concepts solve current scientific or technical problems in novel ways?
Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is the PI capable of coordinating and managing the proposed research team partnership? Are the investigators (partners) appropriately trained in their disciplines and capable of conducting and contributing to the management of the proposed interdisciplinary work?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Does the partnership create potential opportunities to foster trans-disciplinary communication and training across traditional boundaries between cancer biology and physical sciences and engineering?
3.A. Additional Review Criteria:
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:
Partnership and leadership: Is the proposed research team partnership adequate for the research? Is there evidence that the partnership will be effectively managed by the PI or project manager? Is the partnership strategy well planned and documented? Is there evidence that the partners from academia or industry can work together effectively, have an impact on achieving the research goals, and disseminate the developed technology?
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
3.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score will not be affected by the evaluation of the budget.
3.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. Reviewers will factor the proposed data sharing plan into the determination of scientific merit or the priority score. A final data sharing plan will be part of the terms and conditions of the award. The NCI will be responsible for monitoring the data sharing policy.
3.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://www.ott.nih.gov/policy/rt_guide_final.html . Investigators responding to this funding opportunity are expected to include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible
The adequacy of the resources sharing plan will be considered by Program staff of the NCI when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Award Criteria.
Section VI. Award Administration Information1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
The NGA will be sent via email or the via postal system to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.
2. Administrative Requirements
All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.)
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
Not Applicable
The following will be considered in making funding decisions:
4. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency ContactsWe encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Gregory J. Downing, D.O., Ph.D.
Director, Office of Technology and Industrial Relations
Office of the Director
National Cancer Institute, NIH, DHHS
Building 31, Room 10A-52, MSC 2580
31 Center Drive
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: [email protected]
2. Peer Review Contacts:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Kathy Dunn
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for express mail)
Telephone: (301) 846-6829
FAX: (301) 846-5720
E-mail: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (Phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants. (See the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/notice-files/not98-084.html.)
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible.
Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm) . At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm.
Required Education on The Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR web site (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Kirschstein-NRSA Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and Title 42 of the Code of Federal Regulations, Part 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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